Diabetes Mellitus, Type IINCT02175537
Microclinic Social Induction Pilot Intervention for Diabetes and Obesity Management in Qatar
A study testing Microclinic Social Induction Diabetes and Obesity Program in people with Diabetes Mellitus, Type II and Overweight and Obesity, run by Microclinic International at 1 site in Qatar.
Trial summary
The purpose of the study is to pilot-phase test the effectiveness of the microclinic social induction model and its effects on behavioral and metabolic outcomes in different levels of social and familial relationships in Qatar. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type II, Overweight and Obesity, Hypertension
- What is being tested?
- Microclinic Social Induction Diabetes and Obesity Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteQatar
- Study dates
- Jun 2014to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over 18 years old
- Mentally competent
- Body Mass Index of 30 or higher
- Body Mass Index of 25 or higher and self-reported pre-diabetes or type II diabetes
Who cannot join
- They do not meet the above criteria
- They are pregnant
- They have significant medical complications that prevent them from making changes to diet or level of physical activity.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to pilot-phase test the effectiveness of the microclinic social induction model and its effects on behavioral and metabolic outcomes in different levels of social and familial relationships in Qatar. The investigators novel microclinic model is based on the principle that both healthy and unhealthy behaviors spread through preexisting social networks. A microclinic is a small group of approximately 2-8 friends or family members who are taught to modify their own behaviors as well as the behaviors of those around them, with a particular focus on the four "M's": Meals, Movement, Monitoring, and Medication. More than social support groups or peer-to-peer interventions, the microclinic model is unique in its focus on the long-term propagation of healthy behaviors throughout a participant's entire social network. Qatar is uniquely positioned (with its central geographic location in the Gulf region and its leadership in science and education) to spearhead a regional intervention focused on managing and preventing diabetes in the Gulf region.
Read the detailed description
This pilot study, "Microclinic Social Induction Intervention for Diabetes and Obesity Management in Qatar," is a two-arm randomized controlled trial of a 7-week condensed intervention to evaluate the efficacy of the microclinic social induction model on propagating lifestyle changes and in improving glycemic and metabolic control in Doha, Qatar.
The microclinic social induction model leverages different levels of social and familial relationships to positively influence behaviors relating to diabetes and other metabolic conditions through small treatment units called 'microclinic groups,' consisting of 2-8 peers and family members of the same social network. The intervention model brings microclinic groups to a larger classroom network (~25 people/class) where each class shares access to a culturally salient diabetes educational curriculum and group support to promote health behavior changes such as improvement in diet, exercise, medication adherence, and blood pressure management to then influence better glycemic and metabolic control.
- Conditions
- Diabetes Mellitus, Type II, Overweight and Obesity, Hypertension, Behavioral Lifestyle Change, Social Change
- Being tested
- Microclinic Social Induction Diabetes and Obesity Program
- Keywords
- Diabetes Mellitus, Type II, Disease management, Obesity, Social Network, Chronic disease, Prevention and control, Education
- Medical subject headings
- Diabetes Mellitus, Type 2, Overweight, Obesity, Hypertension, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microclinic Social Induction Diabetes and Obesity ProgramBehavioural
Microclinics consist of 2-8 individuals from pre-existing social networks (friends, relatives, coworkers, neighbors, etc) that voluntarily participate in ongoing education and medical monitoring from local health care professionals, learning and practicing diabetes management strategies, sharing much-needed medical supplies, and exchanging social support.
| Study group | Role | What they receive |
|---|---|---|
| Microclinic social induction training | Experimental | BMI of 30 and over; or BMI of 25 and over and self-reported pre-diabetes or type II diabetes will receive the Microclinic Social Induction Diabetes and Obesity Program. The intervention is a training on diabetes self-management, disease monitoring, diabetes prevention, prevention of complications, health behavior change, and social network supports in order to improve chronic disease risk factors. Receives: Behavioral: Microclinic Social Induction Diabetes and Obesity Program |
| Controls | No intervention | Receiving no intervention but parallel primary and secondary outcome measures as intervention study arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Change in body weight (and BMI)
Measured: Weekly measurements between baseline and end of trial after 7 weeks
HbA1c
Change in HbA1c from baseline to end of 7-week pilot phase.
Measured: Baseline, end of trial after 7 weeks
Waist circumference
Measured: Baseline, 4th-week midpoint, 7th-week final
Secondary outcomes (2)
Blood Pressure
Systolic and diastolic blood pressure changes
Measured: Baseline, 4th-week midpoint, 7th-week final
Health Profile Survey
Change in overall health seeking and health maintenance behaviors.
Measured: Baseline, end of trial after 7 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type IIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Microclinic International
- Sponsor type
- University, hospital or other
- Collaborators
- Qatar University, Qatar Foundation, Qatar Diabetes Association, Supreme Council Of Health, Qatar, Harvard School of Public Health (HSPH)
- Responsible party
- Sponsor
- Investigators
- Eric L Ding, PhD, Principal investigator, Harvard School of Public Health (HSPH)Daniel Zoughbie, DPhil, Principal investigator, Microclinic International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02175537
- Sponsor's protocol ID
- NPRP2014-2017
- Status last verified
- Dec 2014
- First submitted
- 18 Jun 2014
- Last updated
- 19 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microclinic Social Induction Pilot Intervention for Diabetes and Obesity Management in Qatar
- ClinicalTrials.gov ID
- NCT02175537
- Acronym / sponsor ID
- NPRP2014-2017
- Conditions
- Diabetes Mellitus, Type II, Overweight and Obesity, Hypertension, Behavioral Lifestyle Change, Social Change
- Keywords
- Diabetes Mellitus, Type II, Disease management, Obesity, Social Network, Chronic disease, Prevention and control, Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Microclinic InternationalUniversity, hospital or other
- Collaborators
- Qatar University, Qatar Foundation, Qatar Diabetes Association, Supreme Council Of Health, Qatar, Harvard School of Public Health (HSPH)
- Study start
- Jun 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 26 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to pilot-phase test the effectiveness of the microclinic social induction model and its effects on behavioral and metabolic outcomes in different levels of social and familial relationships in Qatar. The investigators novel microclinic model is based on the principle that both healthy and unhealthy behaviors spread through preexisting social networks. A microclinic is a small group of approximately 2-8 friends or family members who are taught to modify their own behaviors as well as the behaviors of those around them, with a particular focus on the four "M's": Meals, Movement, Monitoring, and Medication. More than social support groups or peer-to-peer interventions, the microclinic model is unique in its focus on the long-term propagation of healthy behaviors throughout a participant's entire social network. Qatar is uniquely positioned (with its central geographic location in the Gulf region and its leadership in science and education) to spearhead a regional intervention focused on managing and preventing diabetes in the Gulf region.
Detailed description
This pilot study, "Microclinic Social Induction Intervention for Diabetes and Obesity Management in Qatar," is a two-arm randomized controlled trial of a 7-week condensed intervention to evaluate the efficacy of the microclinic social induction model on propagating lifestyle changes and in improving glycemic and metabolic control in Doha, Qatar.
The microclinic social induction model leverages different levels of social and familial relationships to positively influence behaviors relating to diabetes and other metabolic conditions through small treatment units called 'microclinic groups,' consisting of 2-8 peers and family members of the same social network. The intervention model brings microclinic groups to a larger classroom network (~25 people/class) where each class shares access to a culturally salient diabetes educational curriculum and group support to promote health behavior changes such as improvement in diet, exercise, medication adherence, and blood pressure management to then influence better glycemic and metabolic control.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microclinic social induction training | Experimental | Behavioral: Microclinic Social Induction Diabetes and Obesity ProgramBMI of 30 and over; or BMI of 25 and over and self-reported pre-diabetes or type II diabetes will receive the Microclinic Social Induction Diabetes and Obesity Program. The intervention is a training on diabetes self-management, disease monitoring, diabetes prevention, prevention of complications, health behavior change, and social network supports in order to improve chronic disease risk factors. |
| Controls | No intervention | –Receiving no intervention but parallel primary and secondary outcome measures as intervention study arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Over 18 years old
- Mentally competent
- Body Mass Index of 30 or higher
- Body Mass Index of 25 or higher and self-reported pre-diabetes or type II diabetes
Key exclusion criteria (3 listed)
- They do not meet the above criteria
- They are pregnant
- They have significant medical complications that prevent them from making changes to diet or level of physical activity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microclinic Social Induction Diabetes and Obesity ProgramMicroclinics consist of 2-8 individuals from pre-existing social networks (friends, relatives, coworkers, neighbors, etc) that voluntarily participate in ongoing education and medical monitoring from local health care professionals, learning and practicing diabetes management strategies, sharing much-needed medical supplies, and exchanging social support. | Behavioural | Microclinic social induction training |
Primary outcome
Weight
Time frame: Weekly measurements between baseline and end of trial after 7 weeks
Change in body weight (and BMI)
HbA1c
Time frame: Baseline, end of trial after 7 weeks
Change in HbA1c from baseline to end of 7-week pilot phase.
Waist circumference
Time frame: Baseline, 4th-week midpoint, 7th-week final
2 secondary outcomes
Blood Pressure
Time frame: Baseline, 4th-week midpoint, 7th-week final
Health Profile Survey
Time frame: Baseline, end of trial after 7 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric L Ding, PhD principal investigator
Harvard School of Public Health (HSPH)
Daniel Zoughbie, DPhil principal investigator
Microclinic International
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microclinic Social Induction Diabetes and Obesity Program in people with Diabetes Mellitus, Type II and Overweight and Obesity, run by Microclinic International at 1 site in Qatar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Qatar. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: Weekly measurements between baseline and end of trial after 7 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2014.